Phase II Study of the Effect of the Topical Corticosteroid Fluocinonide in Patients on Endocrine Therapy for Either Breast Cancer or an Increased Risk for Breast Cancer With Symptoms of Vaginal Dryness and Dyspareunia

Decrease in symptoms of vaginal dryness and dyspareunia [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]

Decrease in symptoms of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to five (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.

Estimates of decrease will be obtained utilizing patient survey instruments. Vaginal itching will be graded on an ordinal scale of zero to five (none, mild, moderate, severe, and very severe, respectively). Generalized estimating equation (GEE) methods will be used to characterize changes in vaginal symptom scores over time. GEE methods permit the analysis of correlated normal and non-normal data (e.g., binary and ordinal data) and evaluation of fixed and time-dependent covariates (e.g., age, menopausal status, duration of vaginal symptoms, and type of adjuvant endocrine therapy).

I. To estimate the decrease in symptoms of vaginal dryness and dyspareunia with the use of fluocinonide 0.05% cream in breast cancer subjects and subjects at increased risk for breast cancer on endocrine therapy. Estimates of decrease will be obtained utilizing patient survey instruments.

SECONDARY OBJECTIVES:

I. To estimate the decrease in symptoms of vaginal itching and the total vaginal index score with the use of fluocinonide 0.05% cream in breast cancer subjects and subjects at increased risk for breast cancer on endocrine therapy. Estimates of decrease will be obtained utilizing patient survey instruments.

III. To explore correlation between subject reported compliance, as well as compliance via measurement of the amount of fluocinonide 0.05% cream used, and response rates with the use of fluocinonide 0.05% cream.

IV. To explore the correlations between patient characteristics and response rates with the use of fluocinonide 0.05% cream.

Adult women (both pre-menopausal and post-menopausal women are eligible) and with a history of breast cancer or with an increased risk for breast cancer on current treatment with tamoxifen or an aromatase inhibitor with the presence of vaginal dryness or dyspareunia of sufficient severity to make the subject patient desire therapeutic intervention

Vaginal dryness or dyspareunia must be present for at least two months prior to study entry

Subjects must be on current treatment with tamoxifen or an aromatase inhibitor for at least two months prior to study enrollment (defined as the date of consent) and should not be planning to discontinue treatment or to change dose or type of endocrine treatment during the duration of the study

Subjects must agree to not use any over-the-counter or prescription vaginal preparations (lubricants, creams, gels, ointments, solutions) during the four weeks of treatment with topical fluocinonide cream

Subjects must agree to not use any medications, products, or preparations known to contain estrogen during the four weeks of treatment with topical fluocinonide cream

Eastern Cooperative Oncology Group (ECOG) performance status =< 2

Subjects must have ability to read, comprehend, and complete patient questionnaires independently or with assistance

Subjects must sign informed consent

Subjects must agree to read patient instructions regarding use of barrier contraceptive devices while on treatment with fluocinonide cream in the informed consent

Exclusion Criteria:

Use of any vaginal preparations within one week prior to study enrollment (exception: subjects currently using a vaginal preparation can enroll after discontinuing treatment for 7 days)

Use of any estrogen containing medications, products, or preparations

Use of any systemic oral or parenteral steroid containing medications is not permitted; use of "High Daily Dose" inhaled/intranasal corticosteroids is not permitted; use inhaled/intranasal corticosteroid preparations at dosing levels less than "High Daily Dose" is permitted

Current or past treatment with fluocinonide cream for vaginal dryness, itching, or dyspareunia

No prior chemotherapeutic treatment for any malignancy other than breast cancer

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01422408